Recall Z-0481-2011 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Howmedica Osteonics Corp.
T2 Ankle Arthrodesis System Nail and Nut Adapter; Stryker Trauma GmbH, Germany; Distributed in USA by Howmedica, Osteonics Corp., 325 Corporate Drive, Mahwah, NJ
| Date | Nov 26, 2010 (initiated Aug 2, 2006) |
| Status | Terminated |
| Reason | The thread of the nut which should fix the nail adaptor to the targeting arm may seize on the threat of the nail adaptor, interrupting surgery. |
| Root cause | Other |
| Action | Stryker Orthopedics issued an Important Stock Recovery letter dated August 2, 2006 The customer was instructed to inspect inventory for the affected product and return it to the firm. The customer was asked to complete and return a Product Accountability Form and contact their Stryker representative for replacement product. Stryker can be contacted about this issue at 201 831-5118. |
| Quantity | 8 sets |
| Distribution | Nationwide Distribution: To one location in New Jersey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.